Full thickness resection device

ABSTRACT

An operating head for a full thickness resection system includes a first optical device disposed on a distal portion thereof and having a viewing area extending distally of the distal portion and a working chamber extending within an exterior wall of the operating head, a first portion of the exterior wall being moveable with respect to a second portion thereof to selectively open the working chamber to an exterior of the operating head. Furthermore, the operating head includes a second optical device mounted within the working chamber with a viewing area of the second optical device extending distally therefrom.

The present application is a Continuation of application of U.S. patentapplication Ser. No. 10/453,367 filed on Jun. 3, 2003 now U.S. Pat. No.7,300,445 entitled “Full Thickness Resection Device” is a Continuationof U.S. patent application Ser. No. 09/994,518 filed Nov. 26, 2001 U.S.Pat. No. 6,605,078, entitled “Full Thickness Resection Device” Thedisclosures of these applications is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to full thickness resection devices forperforming localized resections of lesions.

BACKGROUND OF THE INVENTION

Resection procedures involve excising a portion of an organ,approximating the surrounding tissue together to close up the holecreated by the excision, and removing excess tissue. Variousconventional devices and procedures are available for resectioninglesions in organs.

For example, several known resection devices and procedures require atleast one incision in an area near the portion of the organ to beexcised for access to the lesion or treatment site (because, forexample, these resectioning devices may lack steering and/or viewingcapabilities). Thus, an incision is required to allow a physician toaccess the organ section to be excised and guide the device to thatsection. Alternatively, when the organ section to be excised is beyondthe reach of the surgical device, or if the surgical device is notflexible enough to wind through the organ to the site to be excised, anincision is required to position the device for the procedure. Ofcourse, these incisions are painful and may involve a partial or entireloss of mobility while recuperating from the incision, in addition tothe discomfort associated with the resectioning procedure itself. Inaddition, these incisions may add significantly to the recovery timerequired for the procedure.

One type of conventional resection procedure utilizes a circularstapling instrument in which a tubular section of a substantiallytubular organ is excised, resulting in the organ being separated intofirst and second segments. The open ends of these first and secondsegments are then tied in a purse-string fashion, approximated towardone another and stapled together. The tissue radially inside the stapledareas (i.e., the “purse-stringed” end sections) is then cut off to openthe interiors of the two segments to one another. In this full circleresectioning procedure, at least one incision must be made near thesection to be excised in order to cut and “purse string” the endsections of the first and second segments. Also, a second incision isnecessary to place one part of the resectioning device in the firstsegment and a corresponding second part of the device in the secondsegment. Thus, this type of resectioning procedure involves thedrawbacks mentioned above in regard to procedures requiring invasiveincisions. In addition, the separation of the organ into two segmentscreates the risk of spillage of non-sterile organ contents into thesterile body cavity, which may cause severe infection and possiblydeath.

An alternative resectioning device includes a stapling and cuttingassembly on a shaft which may be bent or formed into a desired shape andthen inserted into a patient's body cavity. Once the shaft has been bentinto the desired shape, the rigidity of the shaft ensures that the shapeis maintained throughout the operation. This arrangement limits theeffective operating range of the device as the bending of the shaft intothe desired shape before insertion and the rigidity of the shaft oncebent require the physician to ascertain the location of the organsection to be removed before insertion, and deform the shaftaccordingly. Furthermore, the rigidity of the shaft makes it difficultto reach remote areas in the organ—particularly those areas which mustbe reached by a winding and/or circuitous route (e.g., sigmoid colon).Thus, an incision may be required near the organ section to be excisedin order to position such a device at the organ section to be excised.

A full-thickness resection system has been disclosed by the presentApplicant along with others in U.S. Pat. No. 6,126,058, the disclosureof which is expressly incorporated herein by reference in its entirety.The system utilizes a flexible endoscope slidably received through atleast a portion of a stapling mechanism.

SUMMARY OF THE INVENTION

The present invention is directed to an operating head for a fullthickness resection device, comprising a first optical device disposedon a distal portion thereof, the first optical device having a viewingarea extending distally of the distal portion and a second opticaldevice mounted within a working chamber extending within an exteriorwall of the operating head, wherein a first portion of the exterior wallis moveable with respect to a second portion thereof to selectively openthe working chamber to an exterior of the operating head.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of a full thickness resection device accordingto one embodiment of the present invention;

FIG. 2 shows a front view of the full thickness resection device shownin FIG. 1;

FIG. 3 shows a side view, in partial cross section, of the fullthickness resection device shown in FIG. 1, where the device is in theopen position;

FIG. 4 shows a side view, of the full thickness resection device asshown in FIG. 3, where a lesion has been pulled into the device;

FIG. 5 a shows a schematic cross-sectional view of a full thicknessresection device having a movable door, according to another embodimentof the invention;

FIG. 5 b shows a schematic cross-sectional view of a full thicknessresection device as shown in FIG. 5 a where the movable door is in theopen position;

FIG. 6 a shows a side view of a device according to a further embodimentof the invention moving through a body organ along a guide wire;

FIG. 6 b shows a cross-sectional front view of the device according toFIG. 6 a;

FIG. 7 shows a cross-sectional view of an insertion sheath including anintegral custom endoscope according to one embodiment of the presentinvention; and

FIG. 8 shows a cross-sectional view of an insertion sheath including anendoscope receiving lumen according to a further embodiment of thepresent invention.

DETAILED DESCRIPTION

As shown in FIGS. 1 and 2, an optical full thickness resection device 10according to one embodiment of the present invention includes anopenable instrument head 14 which is preferably formed from a frontportion 14 a and a rear portion 14 b. The head 14 may be egg-shaped asshown in FIG. 1. Such a shape allows for the head 14 to be smoothlyinserted into and removed from an organ 50. However, it is understoodthat many other shapes of the head 14 may be employed to ease insertionand removal from the organ 50. For example, the head 14 may bebullet-shaped or, alternatively, may be relatively more spherical. Inthe illustrated embodiment, the head 14 may preferably have a diameterin the range of 10 to 35 mm.

Those skilled in the art will recognize that the organ 50 may includethe colon, the small bowel, the esophagus, or a variety of other organsin which endoscopic procedures have been conducted.

Conventional endoscopes employed with prior endoscopic full thicknessresection devices incorporated certain functional limitations whichfrustrated attempts to reduce their size. These devices were employed ina wide variety of procedures and included features which were notutilized in the full thickness resection procedure. For example, theseendoscopes included one or more working channels through which anoperator might perform therapeutic and/or diagnostic tasks. Furthermore,these endoscopes may also incorporate an insertion tube shaft to enablethe operator to push the endoscope through a body lumen. These workingchannels and the insertion tube add significantly to the diameter of theendoscope. As discussed below, the present invention proposes anendoscope-like device in which these elements are eliminated asunnecessary to the full thickness resectioning procedure.

FIG. 2 shows a cross-sectional view of the front end of a front portion14 a, including additional features of the device 10. In one embodiment,a movable optic device 12 and an irrigation source 13 are provided onthe front portion 14 a with the optic device 12 providing an interiorview of the organ 50 to an operator of the device 10. The irrigationsource 13 allows a solution such as saline to be introduced into theorgan 50 in order to clear debris therefrom improve the operator's view.Additionally provided are light sources 22 for illuminating the organ 50so that the optic device 12 captures a satisfactory image for theoperator. In one embodiment, the optic device 12 may include a visionchip which may include, for example, both photosensors and parallelprocessing elements. According to an exemplary embodiment of the device10, an infusion port 24 allows the operator to inject air or an inertgas into the organ 50 to insufflate the organ. This insufflation of theorgan 50 may further improve the operator's view by distending the wallsof organ 50.

In the illustrated embodiment, an insertion sheath 40 serves to propelthe head 14 through tubular organ 50. In this instance, the insertionsheath 40 which may be formed of a flexible polymeric material such as,for example, polypropylene, is part of an insertion sheath propulsionsystem and constructed, for example, as described in U.S. Pat. Nos.5,259,364 and 5,586,968 to Bob et al., the entire disclosures of whichare hereby incorporated by reference. The insertion sheath 40 isslidably received around an insertion tube 18 which is of reduceddiameter relative to the head 14.

As described more fully below in regard to FIG. 7, the insertion tube18′ may preferably be constructed substantially similarly to knownendoscopes including similar steering and other operating mechanisms butwith a reduced diameter with respect to these known endoscopes as noinsertion tube is required. Those skilled in the art will understandthat the diameter of the insertion tube 18′ may be further reduced if noworking channels are required therein. That is, although FIG. 7 shows asingle working channel 72, for certain operations this working channel72 may be unnecessary. Thus, an insertion tube 18′ for use in suchoperations may include an integral endoscope 100 with no such workingchannel 72 and the diameter of the endoscope 100 (and, consequently,that of the insertion tube 18′, may be further reduced.

If a propulsion system is to be used, the column strength of theinsertion tube 18 may be substantially reduced as the column strengthnecessary to allow a standard endoscope to be pushed through an organ isno longer necessary. Furthermore, as the insertion tube 18 is receivedwithin the insertion sheath 40, no separate insertion tube shaft isincorporated therein as would be the case in a standard endoscope,thereby enabling the diameter of the insertion tube 18 to be furtherreduced with respect to conventional endoscopes. Thus, the diameter ofthe insertion tube 18 may preferably be in the range of 5 to 25 mm withan outer diameter of the insertion sheath 40 being between 10 and 30 mm.Of course, those skilled in the art will understand that these valuesmay be made larger or smaller as desired so long as the flexibility andsteering capacity of the insertion tube 18 in conjunction with theinsertion sheath 40 substantially matches that of conventionalendoscopes.

The insertion sheath 40 is longitudinally flexible so as not to impairthe flexibility of the insertion tube 18 and the steerability of thedevice 10 generally. Thus, when a distal end of the insertion sheath 40abuts against a proximal end of the head 14 and an operator engages theinsertion sheath 40 distally into the organ 50, the head 14 is advancedfurther into the organ 50.

However, it is understood that other propulsion arrangements may be usedwith the device 10. For example, a crawler system (not shown) may beused to move head 14. Such a crawler system may be constructed, forexample, as described in U.S. Pat. No. 5,398,670 to Ortiz et al., andU.S. Pat. No. 5,906,591 to Dario et al. the entire specifications ofwhich are hereby incorporated by reference. In yet another embodiment asshown in FIGS. 6 a and 6 b, a guidewire 60 is placed in the organ 50using a conventional endoscope as is known in the art. The guidewire 60is then strung through the device 10 via a guidewire opening 62 at thefront portion 14 a of head 14 and the device 10 is pushed along theguidewire 60 to the desired location within the organ 50. In order toaccommodate the force exerted on the device 10 as it is pushed into theorgan 50, the insertion tube of the device 10 according to thisembodiment is formed with an increased column strength relative toembodiments in which a propulsion system is employed.

As shown in FIGS. 3 and 4, in one embodiment, fins 16 are disposed at aproximal end of rear portion 14 b. Preferably two or more fins 16 areprovided on opposing sides (180° degrees apart) of the rear portion 14b. Alternatively, one fin 16 may be used. The fins 16 provide a solidsurface against which the insertion sheath 40 may abut to push device 10through the organ 50. Also, the fins 16 serve to prevent portions of thetubular organ 50 from becoming entangled with the insertion sheath 40.

Now turning to FIG. 3, the head 14 is shown in an open position in whichthe front portion 14 a is slid forward to expose an interior work area15. A main optic device 32 is provided at the rear of the rear portion14 b. Preferably, the device 32 points in a generally forward directionas shown in FIG. 3. A base portion 25 of the interior work area 15 mayinclude an auxiliary optic device 26 that points in a directiongenerally perpendicular to the direction of main device 32. The opticdevices 32 and 26 may be illuminated by illumination sources 34 and 28,respectively, to help provide a satisfactory image for the operator. Aswith the exterior optic device 12, the optic devices 32 and 26 maypreferably include vision chips. As will be discussed in connection tothe operation of the device 10, the multiple viewing angles provided bythe optic devices 32 and 26 allow for an improved method of resectioningtissue. In a preferred embodiment, a suction lumen 36 extends from theproximal end of the device 10 to a port 35 that opens into the work area15 so that, when suction is drawn therethrough, tissue adjacent to thehead 14 is drawn into the work area 15. An anvil 64 is positioned in thework area 15 to work in conjunction with a stapler 62 for staplingtissue received therein. Furthermore, a knife 66 is movably mountedwithin the work area 15 to cut tissue received therein radially inwardwith respect to a perimeter of staples delivered by the stapler 62.

A controller 21 is also provided for controlling each of the componentsdiscussed above. The controller 21, which may be used by the operator asa handle, may include a plurality of actuators coupled to the head 14and, in turn, to the various components thereof by a one or more wiresor flexible drive cables 19 as would be understood by those of skill inthe art. The cables 19 may pass through the insertion tube 18 and intothe head 14. Alternatively, the actuators of the controller 21 may becoupled to these components by electric cables and/or by means of remotecontrol (e.g., radio transmission) to actuate electric motors, as wouldbe understood by those of skill in the art, to drive the components asdesired by the operator. By manipulating the actuators of the controller21, the operator may, for example, adjust the optic devices 26 and 32,the illumination sources 28 and 34 as well as any other components ofthe head 14.

In an alternative embodiment of the invention shown in schematic viewsin FIGS. 5 a and 5 b, the head 14 includes a door 70 instead of theseparable front and rear portions 14 a and 14 b of the previouslydescribed embodiment. The door 70 is movable between open and closedpositions so that, in the open position, the interior of the organ 50 isaccessible to the interior work area 15, as described in the previouslydescribed embodiment. With the exception of this difference theapparatus according to this embodiment may function substantiallysimilarly to the other embodiments.

In operation, the head 14 is maintained in the closed position, as shownin FIG. 1, while the device 10 is being maneuvered to the desiredlocation within the organ 50. When the desired location has been foundusing the exterior optic device 12, with the aid of illumination fromlight source 22, to view the interior of the organ 50. As describedabove, to further aid in locating the site, an operator may wash debrisaway from areas being viewed using the irrigation source 13 and/or byinsufflating the organ 50. As described above, resectioning at thisdesired location may be necessary due to, for example, the presence of alesion 52 as shown on the wall of the organ 50 in FIGS. 3 and 4.

Once the head 14 has been positioned as required, the interior work area15 may be exposed by sliding the front portion 14 a away from the rearportion 14 b of the head 14 using the controller 21. In this position,the optic device 26 on the base portion 25 may be used to view thelesion 52. Moreover, the light source 28 provides the portion of organ50 with the necessary illumination to provide a satisfactory image tothe operator. The operator then draws a partial vacuum in the work area15 through the use of the suction device 35 to draw the lesion 52 intothe work area 15 under visual control of the operator via the opticdevice 32 and the light source 34. Based on this observation, theoperator may also reposition or reorient the head 14, as required.However, once the lesion 52 has been sufficiently drawn into theresectioning chamber 31, the view from the optic device 32 may beobscured by the lesion 52 itself. At this time, the optic device 26 maybe used to provide continuing observation of the lesion 52 and itsgeometry with respect to the organ 50.

The tissue surrounding the lesion 52 may now be stapled using thestapler 62 in conjunction with the anvil 64 and, after the staplingoperation has been completed, the knife 66 may be actuated to cut thelesion 52 from the organ 50. The operator then utilizes the controller21 to slide the front portion 14 a toward the rear portion 14 b of thehead 14 until the head 14 is sealed in the closed position. The lesion52 is then retained within the work area 15 until the head 14 has beenremoved from the patient's body, at which time it may be further studiedto aid in the patient's diagnosis and/or treatment.

As shown in FIG. 7, an insertion tube 18′ according to a firstembodiment of the invention may include an integral endoscope 100. Thecustom endoscope 100 includes a steering mechanism comprising controlwire guides 80 (in this case 4 guides 80) which are coupled to a distaltip of the integral endoscope 100 as is known in the art. In addition,the integral endoscope 100 includes a single, optional working channel82, an optic member 84, an irrigation channel 86, one or more lightsource members 88 (in this case 2 light source members 88) and asuction/insufflation lumen 90. As would be understood by those of skillin the art, the optic member 84 may be either a fiber optic cable or anelectric cable depending on the type of optic system employed.Similarly, the light source members 88 may be fiber optic light cablesor electric cables if, for example, one or more LED light source membersare employed at the distal tip of the integral endoscope 100 toilluminate a viewing area of the optic member 84. Those skilled in theart will understand that the irrigation channel may be employed tosupply irrigation fluid to a distal end of the optic member 84 (e.g., alens) to clean the distal end to maintain the field of vision for anoperator of the device.

FIG. 8 shows an alternate embodiment of an insertion tube 18″. Theinsertion tube 18″ includes a central endoscope receiving lumen 92,optional working channels 94 and a suction/insufflation lumen 96. Thus,this insertion tube 18″ may be employed with a custom endoscope (notshown) constructed substantially as shown in FIG. 7 including an opticmember, an irrigation channel and light source members. As the insertiontube 18″ includes working channels 94 and the suction/insufflation lumen96, these items may be eliminated from the custom endoscope for use withthis insertion tube 18″ thereby reducing the diameter of the endoscope.The use of this insertion tube 18″ allows the custom endoscope insertedthrough the endoscope receiving lumen 92 to be reused, as would beunderstood by those of skill in the art.

Those skilled in the art will further appreciate that while theapparatus of the present invention has been described with reference toa full thickness resection of the colon, the apparatus may be utilizedin other digestive tract transluminal procedures, and may be introducedtransorally as well as transanally. Also, while certain embodiments havebeen described with reference to custom endoscopes, it will beappreciated that the specific configurations of the customendoscopes/stapler embodiments may be varied. For example, differentarrangements of lumena and control wires, and different coupling meansfor coupling the control wires to the driving gears may be provided withsimilar results obtained. Also, the control wires may be replaced, forexample with flexible cables or hydraulic fluid channels. It willtherefore be appreciated by those skilled in the art that yet othermodifications could be made to the provided invention without deviatingfrom its spirit and scope as so claimed.

1. An operating head for a full thickness resection device, comprising:a first optical device disposed on a distal portion of the device, thefirst optical device having a viewing area extending distally of thedistal portion; a working chamber extending within an exterior wall ofthe operating head, the exterior wall including a door movable between aclosed position and an open position, the working chamber beingaccessible when the door is in the open position, wherein a distancebetween the distal portion and a proximal portion of the device remainsconstant when the door moves between the closed position and the openposition; and a second optical device mounted within the working chamberwith a viewing area extending distally therefrom.
 2. The operating headaccording to claim 1, further comprising an infusion lumen extendingtherethrough to an infusion port in the distal portion.
 3. The operatinghead according to claim 1, further comprising an irrigation lumenextending therethrough to an irrigation port in the distal portion. 4.The operating head according to claim 1, including a first abuttingsurface formed on a proximal end thereof for abutting a distal end of aninsertion sheath so that, advancing the insertion sheath into a bodylumen pushes the operating head further into the body lumen.
 5. Theoperating head according to claim 4, wherein the first abutting surfaceis formed as a first fin disposed on the proximal end.
 6. The operatinghead according to claim 5, further comprising a second abutting surfaceformed on the proximal end, wherein the second abutting surface isformed as a second fin disposed on the proximal end on a portion of theproximal end disposed on an opposite side of a longitudinal axis of theoperating head from the first fin.
 7. The operating head according toclaim 5, wherein the first fin is substantially triangular in shape. 8.The operating head according to claim 5, wherein one of the proximal anddistal portions of the head is slidably mounted to the operating headfor motion relative to the other of the proximal and distal portions toopen the working chamber to the exterior of the operating head.
 9. Theoperating head according to claim 1, further comprising a third opticaldevice with a viewing area extending in a direction approximatelyperpendicular to that of the second optical device.
 10. The operatinghead according to claim 1, further comprising first and second lightsources illuminating the viewing areas of the first and second opticaldevices, respectively.
 11. The operating head according to claim 10,further comprising a third light source illuminating the viewing area ofthe third optical device.
 12. A full thickness resection systemcomprising: a steerable endo scope extending from a proximal end whichremains outside a patient's body during use to a distal end; anoperating head coupled to the distal end of the endoscope and defining aworking chamber therein, wherein a door of an exterior wall of theoperating head is moveable to selectively open the working chamber to anexterior of the operating head, wherein a distance between a distalportion and a proximal portion of the operating head remains constantwhen the door moves between a closed position and an open position;first and second optical devices, the first optical device having aviewing area extending distally of the distal portion of the operatinghead and the second optical device having a viewing area extendingdistally from the working chamber of the operating head; and acontroller coupled to the proximal end of the endoscope for controllingoperation of the endoscope and the operating head.
 13. The systemaccording to claim 12, further comprising an infusion lumen extendingthrough the endoscope to an infusion port formed in the operating head.14. The system according to claim 12, further comprising an irrigationlumen extending through the endoscope to an irrigation port formed inthe operating head.
 15. The system according to claim 12, furthercomprising an insertion sheath slidably received around the endoscope sothat a distal end of the insertion sheath abuts against the operatinghead so that advancing the insertion sheath into a patient's body movesthe operating head further into the patient's body.
 16. The systemaccording to claim 15, further comprising an abutting surface formed onthe proximal end of the operating head.
 17. The system according toclaim 16, wherein the abutting surface is formed as a fin extendingtherefrom of the second optical device.
 18. The system according toclaim 15, wherein the insertion sheath includes a working channel and afluid channel extending therethrough.
 19. The system according to claim18, wherein the fluid channel is adapted to be used in one ofinsufflation and suction operations.
 20. The system according to claim15, wherein an outer diameter of the insertion sheath is between 5 and25 mm.
 21. The system according to claim 15, wherein the endoscope isremovable from the insertion sheath.
 22. The system according to claim15, wherein the endoscope is permanently mounted to the insertionsheath.
 23. The system according to claim 12, further comprising a thirdoptical device mounted within the working chamber, a viewing area of thethird optical device extending in a direction substantiallyperpendicular to that of the second optical device.